Trial Title:
Risk Stratified De-escalated Hormone Therapy with Radiation Therapy for the Treatment Prostate Cancer
NCT ID:
NCT06369610
Condition:
Oligometastatic Prostate Carcinoma
Prostate Adenocarcinoma
Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma
Abiraterone Acetate
Hormones
Prolactin Release-Inhibiting Factors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone Acetate
Description:
Given abiraterone acetate
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
BR9004
Other name:
BR9004-1
Other name:
CB7630
Other name:
JNJ-212082
Other name:
Yonsa
Other name:
Zytiga
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Biological
Intervention name:
Gonadotropin-releasing Hormone Analog
Description:
Given SC or IM
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
GnRH Agonist
Other name:
GnRH Analog
Other name:
Gonadotropin-Releasing Hormone Agonist
Other name:
Gonadotropin-Releasing Hormone Analogue
Other name:
LH-RH agonist
Other name:
LH-RH Analogs
Other name:
LHRH Agonist
Other name:
luteinizing hormone-releasing hormone agonist
Other name:
Luteinizing Hormone-Releasing Hormone Analog
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo radiation therapy
Arm group label:
Group I (radiation therapy)
Arm group label:
Group II (ADT, radiation therapy)
Arm group label:
Group III (ADT, radiation therapy, abiraterone acetate)
Other name:
Cancer Radiotherapy
Other name:
Energy Type
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Summary:
This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer
treatments) with radiation works in treating patients with prostate cancer. Androgen
deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and
abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by
the body. This may help kill or stop the growth of tumor cells that need testosterone to
grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill
cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for
patients with high-risk prostate cancer. However, there are few studies that determine
ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation
therapy may be as effective as giving more ADT in treating high-risk prostate cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. Recovery of the Expanded Prostate Cancer Index Composite (EPIC) hormonal domain to
baseline levels at 2-years.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months
(Common Terminology Criteria for Adverse Events [CTCAE] version 5.0); Ib. Grade 3 or
greater GU and GI toxicity at 6 months (CTCAE version 5.0); Ic. Patient-reported quality
of life; Id. Impotence after the use of radiation therapy at 3 years; Ie. Freedom from
biochemical failure (FFBF) at 5 years; If. Clinical failure: local and/or distant at 5
years; Ig. Salvage androgen deprivation use (SAD) at 5 years; Ih. Progression free
survival: using clinical, biochemical and SAD as events at 5 years; Ij. Overall survival
at 5 years; Ik. Disease-specific survival at 5 years. II. Determine overall GI and GU
toxicity.
OUTLINE: Patients are assigned to 1 of 3 risk groups.
GROUP I (LOW RISK): Patients undergo radiation therapy to the prostate bed over 2 - 6
weeks.
GROUP II (INTERMEDIATE RISK): Patients receive ADT subcutaneously (SC) or intramuscularly
(IM) for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on
week 8-10 of ADT hormone therapy.
GROUP III: (HIGH RISK): Patients receive ADT SC or IM with or without abiraterone acetate
for up to 18 months in the absence of disease progression or unacceptable toxicity.
Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on
week 8-10 of ADT hormone therapy.
Additionally, patients undergo positron emission tomography (PET), computed tomography
(CT) or magnetic resonance imaging (MRI), and blood sample collection throughout the
trial.
After completion of study treatment, patients are followed up at months 3 and 12, then
yearly for up to year 5 followed by every 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed high risk prostate adenocarcinoma
- Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC
Criteria 8th Edition [Ed].)
- One or more high risk features including Gleason 8-10, T3-T4, prostate specific
antigen (PSA) ≥ 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must sign institutional review board (IRB) approved study specific informed
consent
- Patients must complete all required pre-entry tests
- Patients must be at least 18 years old
- Oligometastatic prostate cancer defined as disease in up to 5 distant or regional
areas
Exclusion Criteria:
- Previous pelvic radiation
- Prior androgen suppression therapy for prostate cancer for more than 6 months
- Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative
colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are
allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin,
low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless
it can be stopped to manage treatment related toxicity, to have a biopsy if needed,
or place markers)
- Major medical, addictive or psychiatric illness which in the investigator's opinion,
will prevent the consent process, completion of the treatment and/or interfere with
follow-up. (Consent by legal authorized representative is not permitted for this
study)
- Evidence of any other cancer within the past 5 years and < 50% probability of a 5
year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous
cell cancer of the skin is allowed)
- History of myocardial infarction or decompensated congestive heart failure (CHF)
within the last 6 months
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Carlos E. Vargas, M.D.
Start date:
April 22, 2024
Completion date:
April 22, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06369610
https://www.mayo.edu/research/clinical-trials
